Skip to content

Aequalis™ Ascend™ Flex DWF607ARecalls & reported problems

Tornier · Class 2 · Implant

All models of Aequalis Ascend Flex (30)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386944659), received between Mar 2, 2018 and Jun 4, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Device Contaminated During Manufacture or Shipping2

Patient problems

  • Patient Problem/Medical Problem3
  • Unspecified Infection1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016. ON (B)(6) 2017, REVISION SURGERY FOR INFECTION WAS PERFORMED (CONVERSION OF THE REVERSE SHOULDER ARTHROPLASTY (RSA) TO HRP. ALL TORNIER COMPONENTS WERE REMOVED.

    Patient problems: Unspecified Infection

    MAUDE report 11942444 ↗
  • MalfunctionSep 4, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    DIFFERENT STEMS AND ALL OF THEM HAD A WHITE PAINT LIKE SUBSTANCE ON THEM. THE ISSUE OCCURRED IN SURGERY, THE PATIENT WAS UNDER ANESTHESIA AND THERE WAS AN ADDITIONAL DELAY OF 30-40 MIN.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 7841867 ↗
  • MalfunctionSep 4, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    DIFFERENT STEMS AND ALL OF THEM HAD A WHITE PAINT LIKE SUBSTANCE ON THEM. THE ISSUE OCCURRED IN SURGERY, THE PATIENT WAS UNDER ANESTHESIA AND THERE WAS AN ADDITIONAL DELAY OF 30-40 MIN.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 7841862 ↗
  • InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ROTATOR CUFF INSUFFICIENCY 5 YEARS POST-OPERATIVE. PATIENT ID: (B)(6)"

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 7308959 ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page